Senior CMC Regulatory Technical Writer

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

Main Responsibilities:

• Author, review, and finalize high-quality CMC sections (Module 2.3 and Module 3) for Phase 3 and Marketing Authorization Applications
• Prepare briefing documents and responses to Health Authority questions as required
• Collaborate with CMC technical teams (process development, formulation, analytical, manufacturing) to collect and interpret data
• Ensure alignment of all documentation with global regulatory requirements (ICH, FDA, EMA)
• Develop, maintain, and continuously improve CMC regulatory dossier templates in line with evolving guidelines
• Manage submission workflows within the electronic document management system (eCTD environment)
• Ensure consistency, accuracy, and scientific integrity of all regulatory narratives
• Manage timelines across multiple projects and proactively communicate risks
• Provide guidance and support to internal stakeholders when needed

Requirements:
About You

We are looking for a detail-oriented and experienced regulatory technical writer with a solid background in CMC documentation.

Experience: Minimum 10 years of experience in CMC within the pharmaceutical industry and CMC regulatory technical writing

Skills: Excellent writing, editing, and organizational skills. Strong understanding of regulatory requirements and guidelines (ICH, FDA, EMA, etc.). Ability to work collaboratively in a fast-paced environment.

Education: Degree in Pharmacy or a relevant scientific field (Chemistry, Biology, or equivalent).

Languages: Fluent in written and spoken English

Benefits:
Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.